Archive for April, 2017

A federal jury in Illinois recently held GlaxoSmithKline liable for the death of a Reed Smith LLP partner, Stewart Dolin. The jury found that the generic version of GSK’s Paxil caused Mr. Dolin to take his own life, awarding $3 million to his widow.

Dolin began taking the generic version of Paxil, paroxetine, five days before taking his own life. In the lawsuit, Dolin’s widow claimed the drug caused a heightened anxiety known as “akathisia” in the 57-year-old that caused his death.

The lawsuit claimed that GSK knew about the increased risk of suicide for adults taking paroxetine. The plaintiff alleged the company had hidden data proving the link from the U.S. Food and Drug Administrationfor decades and ignored suicides in its clinical trial. She alleged GSK had evidence paroxetine increases the risk of suicide by older users by as much as 670 percent, yet failed to include that on the warning label.

GSK denied that paroxetine caused Mr. Dolin’s suicide, arguing that the FDA does not require Paxil to come with a warning that it can increase the risk of suicide in adults. The drug’s label does include a “black-box” warning that it can increase the risk of suicidal behavior by users under age 25.

GSK also argued that Mr. Dolin’s suicide was a result of his years-long battle with anxiety and stress related to his work as co-chair of Reed Smith’s corporate and securities practice. GSK presented therapy records showing Mr. Dolin had concerns about his new role at Reed Smith, as well as evidence of other work-related performance issues. Ms. Dolin testified during the trial that while her husband was sometimes anxious, he had developed coping mechanisms to deal with that anxiety and was seeing a therapist at the time of his death.

The lawsuit originally included Mylan, the manufacturer of the generic medication, but a federal judge dismissed Mylan in 2014. Splitting with some previous rulings on this issue, the judge found that even though GSK did not manufacture the drug at issue, it controlled the drug’s design and label, which applied to both the brand name and generic versions. The judge held that Mylan was bound by statute to use GSK’s warning label, and thus GSK was the responsible party.

From the common law period through 2011, the Commonwealth operated under a system of joint and several liability. Joint and several liability meant that any and all defendants were “in for a penny, in for a pound.” Any defendant found liable – even 1% liable – was on the hook for the full amount of the judgment, resulting in countless verdicts where insured Defendants who were Co-Defendants with judgement-proof individuals paid out full judgments. Pennsylvania struggled for the better part of a decade to craft a law that would end joint and several liability and finally passed the Fair Share Act. As the name implies, individual defendants are now responsible solely for their proportionate share of the judgment. There are some exceptions; for example, a defendant found more than 60% liable remains liable to pay the full amount of the judgment. At the time of its passage in 2011, Pennsylvania’s Fair Share Act was hailed by defense counsel as rectification of inequity. However, with the litany of exceptions and without guidance as to the application of the Act to Pennsylvania’s Suggested (read: Compulsory) Jury Instructions, practitioners and the courts have struggled to apply the Act at trial.

The Fair Share Act is particularly thorny when applied to Pennsylvania’s notoriously plaintiffs-friendly products liability and mass torts jurisprudence. (Products Liability, in particular, has already been in a state of flux since the seminal 2014 decision of the Pennsylvania Supreme Court in Tincher v. Omega Flex, `04 A.3d 328 (Pa. 2014), which struck down the Commonwealth’s bright-line separation between negligence concepts and strict liability principles, but declined to adopt the Third Restatement. Everyone agrees it is seminal. No one agrees as to exactly what. The Pennsylvania Supreme Court is seemingly content to allow that state of affairs to continue indefinitely.)

Pennsylvania’s appellate-level Court, the Superior Court, is currently hearing arguments in Roverano v. John Crane Inc., to determine whether the Fair Share Act requires juries in strict liability cases to determine the portion of liability to be imposed against each defendant, or whether a judge simply apportions liability equally. Trial Courts across Pennsylvania – there are 60 total[1] — have struggled with the question and reached different conclusions. At trial in the matter on appeal, the Judge equally apportioned liability among the 8 Defendants.

At oral argument, Plaintiff’s counsel argued that the Fair Share Act should not apply to strict liability cases as it does to negligence cases (shades of a pre-Tincher Commonwealth rearing its head). However, the Court noted asbestos cases are not one of the Fair Share Act exceptions. In a bit of a role-reversal, it is Plaintiff’s counsel arguing that it is the judge, not the jury, that ought to make the decisions about percentages of fault against defendants in strict liability cases. All counsel, and the judiciary, had little to work with, as a footnote in a separate matter, Rost v. Ford Motor, makes up almost the entirety of precedent about the application of the Fair Share Act to strict liability cases. That, and the ever-changing makeup of the Pennsylvania Supreme Court, which has a full complement of justices for the first time since 2014, makes it extremely difficult to predict how these cases will shake out, and to what extent.

We expect these cases to continue to wind their way through the appellate levels for years, if not decades, to come.

[1] Philadelphia, it goes without saying, is the First Judicial District – No.1

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has announced a $400,000 settlement with Metro Community Provider Network (MCPN), a Federally Qualified Health Center providing primary medical care and other health-related services in the Denver area, of an alleged HIPAA violation which resulted in a data breach due to a 2012 phishing scam. On January 27, 2012, MCPN filed a breach report with the OCR indicating that a hacker had used phishing emails to access employee email accounts, resulting in the compromise of electronic protected health information (ePHI) of 3,200 individuals. The OCR’s investigation of the breach revealed that MCPN had never conducted a security risk analysis of the vulnerabilities of the confidentiality, integrity, and availability of its ePHI prior to the discovery of the breach in violation of HIPAA. Further, once it did do a risk analysis, MCPN failed to do one sufficient to satisfy the HIPAA Security Rule. As part of the settlement, in addition to paying out a fine of $400,000, MCPN has agreed to implement a corrective action plan that requires it to conduct a comprehensive risk analysis and submit a written report to the OCR. Following the risk assessment, MCPN must also develop and enact an organization-wide risk management plan, including reviewing and revising its security policies and procedures and training materials.

This settlement highlights the importance of conducting regular, thorough risk analyses for all organizations subject to the requirements of HIPAA. According to the OCR Guidance, which may be found here, a thorough risk analysis may involve:

Identification of the variety of ePHI an organization creates, collects, maintains, or transmits;

Identification of the location(s) where ePHI is stored;

Identification and documentation of threats to and vulnerabilities to ePHI;

Assessment of current security measures;

Assessment of the potential impact of the threat(s);

Assessment of the level of risk;

Documentation of the overall analysis.

While MCPN failed to do one at all until after it suffered a breach, the belief that doing one is enough is not uncommon. The OCR Guidance on this topic suggests periodic review. Significant changes in organizational structure or size or the implementation of new technology need to equate to updated risk assessments. If you need assistance with your HIPAA risk assessments, FMG’s Cyber Liability, Data Security & Privacy group is here to help.

In a recent, factually interesting decision by an Illinois Court of Appeal, a defense verdict in a dental malpractice case was overturned for a variety of reasons related primarily to the defendant’s expert’s use of skulls during his testimony. However, one of the side issues also piqued my interest. The case involved dental implants, and a treating oral and maxillofacial surgeon provided testimony that the dentist that placed the implants deviated from the applicable standard of care.

During cross-examination by the defendant’s attorney, the oral surgeon was confronted with G.1.08 of the American Association of Oral and Maxillofacial Surgeons’ Code of Professional Conduct titled “Fairness in dealing with colleagues” that reads: “Oral and maxillofacial surgeons who wish to serve as expert witnesses must not do so in cases for which they also served as one of the patient’s treating doctors.” The oral surgeon admitted that he was a treating doctor, but attempted to clarify that the code did not apply to the situation as the dentist that placed the implants was not a “colleague.”

The Illinois Court of Appeals addressed this line of cross-examination. While it was not the issue that formed the basis of the reversal, the court wanted to provide direction to the trial court for the retrial. Specifically, the three-panel opinion determined that the cross-examination was improper and should not have been allowed. The opinion indicated that only the Illinois legislature and the courts may determine the admissibility and proper scope of expert testimony in medical malpractice actions. The private accrediting bodies “may not attempt to thwart their members from testifying as expert witnesses against their colleagues by declaring such testimony to be a violation of professional ethics.” Therefore, the type of questioning was both irrelevant and in violation of public policy and should not have been permitted.

It is interesting because for years, I have had this particular Code of Professional Conduct used by opposing counsel in an attempt to quell the supporting testimony of treating oral surgeons in cases where I was defending the dental professional. Often, the oral surgeon would have expert opinions that the defendant met the standard of care, but this particular ethics consideration was brought to their attention in a pre-deposition meeting with the patient’s attorney, and they would decline to provide such testimony on the record. Thus, the Code of Ethics is being used as both a sword and a shield for expert testimony.

This decision, while not binding in other states, still provides sound arguments for the application of similar issues in our own backyard. Any qualified expert should be able to provide opinions that a medical provider met or deviated from the standard of care, even if they too provided care. The search for truth should not be restricted for either side by the use of an ethical rule as long as the testimony is from a qualified expert and is, in fact, the truth.

U.S. Citizenship and Immigration Services has announced a redesign to the Permanent Resident Card (“Green Card”) and the Employment Authorization Document (“EAD”) as part of the Next Generation Secure Identification Document Project. USCIS will begin issuing the new cards on May 1, 2017.

The new Green Cards and EADs will:

Display the individual’s photos on both sides;

Show a unique graphic image and color palette (Green Cards will have an image of the Statue of Liberty and a predominately green palette, and EAD cards will have an image of a bald eagle and a predominately red palette);

Have embedded holographic images; and

No longer display the individual’s signature.

Also, Green Cards will no longer have an optical stripe on the back.

Some Green Cards and EADs issued after May 1, 2017, may still display the existing design format as USCIS will continue using existing card stock until current supplies are depleted. Both the existing and the new Green Cards and EADs will remain valid until the expiration date shown on the card.

Both versions are acceptable for Form I-9, Employment Eligibility Verification, E-Verify, and Systematic Alien Verification for Entitlements (SAVE). Some older Green Cards do not have an expiration date. These older Green Cards without an expiration date remain valid.

For additional information related to this topic and for advice regarding how to navigate U.S. immigration laws you may contact Layli Eskandari Deal of the law firm of Freeman, Mathis & Gary, LLP at (770-551-2700) or [email protected].